UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010925
Receipt number R000012738
Scientific Title Sarcopenia, Malnutrition in the Geriatric Patient With Oral Cavity Dysfunction
Date of disclosure of the study information 2013/06/17
Last modified on 2015/01/12 11:28:58

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Basic information

Public title

Sarcopenia, Malnutrition in the Geriatric Patient With Oral Cavity Dysfunction

Acronym

Oral Cavity Dysfunction and Sarcopenia

Scientific Title

Sarcopenia, Malnutrition in the Geriatric Patient With Oral Cavity Dysfunction

Scientific Title:Acronym

Oral Cavity Dysfunction and Sarcopenia

Region

Japan


Condition

Condition

Oral cavity dysfunction

Classification by specialty

Geriatrics Rehabilitation medicine Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the relationship between oral cavity function and sarcopenia of skeletal muscle

Basic objectives2

Others

Basic objectives -Others

Incidence

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

muscle mass of skeletal muscle

Key secondary outcomes

1. Revised Oral Assessment Guide (ROAG)
2. muscle strengh
3. nutritional state
4. activities of daily living


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Hospitalized elderly patients under dental treatment

Key exclusion criteria

Patients with edema

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuri Tsuji / Yoshihiro Yoshimura

Organization

Kumamoto Rehabilitation Hospital

Division name

Dental Surgery / Physical Medicine and Rehabilitation

Zip code


Address

760 Magate, Kikuyo-machi, Kikuchi-gun, Kumamoto

TEL

096-232-3111

Email

hanley.belfus@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Yoshimura

Organization

Kumamoto Rehabilitation Hospital

Division name

Physical Medicine and Rehabilitation

Zip code


Address

760 Magate, Kikuyo-machi, Kikuchi-gun, Kumamoto

TEL

096-232-3111

Homepage URL


Email

hanley.belfus@gmail.com


Sponsor or person

Institute

Kumamoto Rehabilitation Hospital

Institute

Department

Personal name



Funding Source

Organization

Kumamoto Rehabilitation Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

熊本リハビリテーション病院(熊本県)


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 06 Month 11 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1. Prospective observational study
2. To evaluate the relationship between oral cavity function and sarcopenia of skeletal muscle
3. To evaluate the efficacy of Revised Oral Assessment Guide (ROAG) score as oral cavity assessment


Management information

Registered date

2013 Year 06 Month 11 Day

Last modified on

2015 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012738


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name